Syntec Pharma Cited for Cross-Contamination

August 6, 2021

The FDA has issued a warning letter to Syntec Pharma for failure to prevent cross-contamination and for other good manufacturing practice lapses at its drug facility in Farmingdale, N.Y.

Based on an FDA inspection carried out Oct. 7 to Oct. 28, 2020, the warning letter cited significant deviations from current good manufacturing practice.

Among other serious deficiencies, the company stored the chemotherapy drug Lomustine and human chorionic gonadotrophin at room temperature instead of under refrigeration as required to prevent degradation, the agency said.

The facility also “kept weed killer, engine antifreeze coolant and dry wall repair products” in the same room where it stored active pharmaceutical ingredients (APIs) and packaging components. And it commingled food items and unidentified products in unlabeled aluminum bags in the refrigerator where it stored APIs and chemicals, the agency said.

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